BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE ACL REPAIR PACK

    MDR report key: 22612765 · Received July 25, 2025

    Report

    Report Number
    MW5173318
    Event Type
    Malfunction
    Date Received
    July 25, 2025
    Date of Event
    July 17, 2025
    Report Date
    July 22, 2025
    Manufacturer
    MEDLINE INDUSTRIES, LP - SPT
    Product Code
    OJH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING A PRE PROCEDURAL COUNT, THE TEAM COUNTED AND VERIFIED 4 LAP SPONGES WERE INCLUDED IN THE SURGICAL PACK WHEN THEY SHOULD COME IN A SET OF 5. THIS WAS RECOGNIZED PRIOR TO THE START OF THE PROCEDURE AND THERE WERE NO ASSOCIATED INCORRECT COUNTS OR PATIENT HARM. ACL REPAIR PACK REF: DYNJ51736, LOT: 24LBA204, EXP: 05/31/2027.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1040329 MEDLINE ACL REPAIR PACK ORTHOPEDIC TRAY OJH MEDLINE INDUSTRIES, LP - SPT 24LBA204

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other